Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

Lead Sponsor:

University College, London

Collaborating Sponsors:

Boehringer Ingelheim

Conditions:

Carcinoma, Non-Small-Cell Lung

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to examine the efficacy and safety of using afatinib (BIBW 2992) to treat non-small cell lung cancer patients considered unfit for chemotherapy and have either suspected o...

Detailed Description

Lung cancer is most common cause of death from cancer, of which non-small cell lung cancer (NSCLC) accounts for \~80% of all cases with most patients presenting with advanced disease. Patients medical...

Eligibility Criteria

Inclusion

  • Any stage not suitable for radical treatment
  • Either:
  • Confirmed activating EGFR mutation (exons 18-21; e.g. L858R, exon 19 deletions, exon 20 insertions, T790M, list is not exhaustive), and WHO PS 0-3 Or No tissue suitable for EGFR genotyping, failed genotype, or EGFR genotyping unavailable, and NSCLC Adenocarcinoma sub-type, and
  • Eligible smoking history:
  • Never smoker (\<100 cigarettes in lifetime), or Former smoker (stopped \>1year ago and ≤10 pack-years) and WHO PS 0-2
  • Unsuitable for or patient declining chemotherapy due to significant co-morbidity
  • Measurable disease according to RECIST version 1.1
  • Adequate haematopoietic, hepatic and renal function defined as follows:
  • Absolute neutrophil count (ANC) ≤1.5 x 109/L and platelet count ≤100 x 109/L
  • Bilirubin ≤1.5 x ULN, ALT (SGPT) ≤3 x ULN (or ≤ 5 x ULN in cases of liver metastases)
  • Serum creatinine clearance ≥45 ml/min
  • Palliative radiotherapy allowed unless to a solitary target lesion
  • Age 18 or over (no upper age limit)
  • Written informed consent that is consistent with ICH-GCP guidelines

Exclusion

  • Previous treatment with afatinib (BIBW 2992), or any EGFR-directed inhibitor
  • Any concurrent anticancer systemic therapy
  • Prior chemotherapy for relapsed and/or metastatic NSCLC
  • Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and registration
  • Suitable for radical radiotherapy
  • Palliative radiotherapy within 2 weeks prior to registration
  • Palliative radiotherapy to a solitary target lesion
  • Surgery (other than biopsy) within 4 weeks prior to registration
  • Inability to take oral medication, requirement for intravenous feeding, active peptic ulcer, prior surgical procedures affecting absorption, any medical co- morbidity affecting gastrointestinal absorption
  • Patients with current or pre-existing interstitial lung disease
  • Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's participation in the trial
  • Significant or recent acute gastrointestinal abnormalities with diarrhoea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE version 4.0 Grade ≥3 diarrhoea of any etiology at baseline
  • Active brain metastases (defined as stable for \<4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants and/or leptomeningeal disease). Steroids will be allowed if administered as a stable (same) dose for at least one month before trial entry.
  • Any other current malignancy or malignancy diagnosed within the past five years (other than non-melanomatous skin cancer and in situ cervical cancer)
  • History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3 or more, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to registration
  • Symptomatic left ventricular failure with NYHA classification of 3 or more
  • Active viral hepatitis and/or known HIV positive
  • Known or suspected active drug or alcohol abuse
  • Use of any investigational drug within 8 weeks of registration.
  • Known allergy to BIBW 2992 or other ingredients.
  • Patients on steroids must have been on the same dose for at least 4 weeks.
  • Inability to understand or to comply with the requirements of the trial, trial protocol or to provide informed consent.
  • Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
  • Women who are pregnant or breast feeding
  • Requirement for treatment with any of the prohibited concomitant medications listed in protocol

Key Trial Info

Start Date :

December 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2018

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT01415011

Start Date

December 1 2012

End Date

November 30 2018

Last Update

January 15 2019

Active Locations (15)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (15 locations)

1

Royal Bournemouth Hospital

Bournemouth, United Kingdom

2

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

3

James Paget University Hospital

Great Yarmouth, United Kingdom

4

East Kent Hospitals

Kent, United Kingdom